Serum GFAP and UCHL1: Evaluation of Their Predictive Value for SAH

NCT06581757 | Terminated

• 1 other identifier: 2024LAB134
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

To verify the analytical performance of GFAP and UCH-L1 biomarkers marketed by Abbott Diagnostics and to assess diagnostic accuracy of these biomarkers in predicting subarachnoid haemorrhage

Conditions

Subarachnoid Haemorrhage (SAH)

Keywords

Subarachnoid haemorrhage; Evaluation; SAH; Glial Fibrillary Acidic Protein; Ubiquitin Carboxy-terminal Hydrolase L1; Cerebrospinal Fluid; Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• Measures of diagnostic accuracy including sensitivity, specificity, negative predictive value and positive predictive value.

  Metrics of diagnostic accuracy to include sensitivity, specificity, negative predictive value and positive predictive value.

  1 year

Study Arms (1)

Residual, surplus serum samples

The study will utilise residual, surplus serum samples with a minimum volume of 300µl that have already been taken as part of the patient's routine care. The patients have already been consented for investigation of SAH and the leftover sample would otherwise be discarded by the laboratory.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to hospitals covered by the black country pathology service (BCPS) who have had a lumbar puncture (LP) for the investigation of subarachnoid haemorrhage.

You may qualify if:

• Patients ≥18 years old, who have had an LP with a serum sample taken within 24 hours of the LP.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will utilise residual, surplus serum samples that have already been taken as part of the patient's routine care. The patients have already been consented for investigation of SAH and the leftover sample would otherwise be discarded by the laboratory. Samples will be identified by the co-investigator, whom is part of the normal clinical care team, using a data gather from the pathology laboratory information management system of patients that have had a serum sample taken within 24 hours of a test for CSF xanthochromia.

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leanne Young

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: January 16, 2025
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)